Key facts

Invented name
Kisqali
Active Substance
ribociclib succinate
Therapeutic area
Oncology
Decision number
P/0218/2020
PIP number
EMEA-002765-PIP01-19
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
Treatment of breast cancer
Route(s) of administration
Oral use
Contact for public enquiries

Novartis Europharm Limited

E-mail: paediatric.enquiries@novartis.com
Tel. +41 6132 41111

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date

Decision

P/0218/2020: EMA decision of 17 June 2020 on the granting of a product specific waiver for ribociclib (succinate) (Kisqali), (EMEA-002765-PIP01-19)

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